- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04035408
Facial Skin Health Tracking Feasibility in Breast Cancer Patients
August 31, 2023 updated by: University of Colorado, Denver
Tracking the Natural History of Facial Skin Health in Pre and Peri Menopausal Breast Cancer Patients Undergoing Chemotherapy and / or Endocrine Therapies: A Feasibility Study
This feasibility study will assess if tracking objective and subjective facial skin changes over time is acceptable to pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer.
There is no intervention arm and no control group.
Skin health will be assessed through the instruments described below, and subjective data will be collected with self-administered questionnaires.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
There are no studies objectively assessing changes to facial skin health in this population, but tools exist to objectively measure changes thus we have chosen to use those tools to measure skin health.
Before embarking on an intervention study showing improvement in skin health and patients' self-image and QOL, we first need to see if 1) it is feasible to measure changes in skin health in this population and 2) if skin health does objectively change over the course of therapy.
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Our baseline skin health self-assessment tool accounts for smoking status, sun exposure, and sunscreen use and this will factor into our assessments/comparison to age and ethnicity matched norms.
Sun exposure will likely affect skin age differences at baseline but should not affect the skin aging over the duration of the study.
Description
Inclusion Criteria:
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study
- Be a pre or perimenopausal woman age 18 or over
- Be a patient with a new diagnosis of breast cancer who plans to undergo systemic chemotherapy or endocrine therapy, but who has not yet started treatment
Exclusion Criteria:
- Postmenopausal status (one year without a menstrual period)
- Pregnant women (pregnancy test not required)
- Prior cancer diagnosis of any type other than breast cancer
- History of prior treatment with chemotherapy or radiation therapy
- Chronic skin disease including scleroderma, discoid lupus, atopic dermatitis, rosacea, eczema, or psoriasis
- Use of a retinoid-based prescription facial skin product within the past 11 month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All subjects
All the enrolled subjects will be considered for the assessment of the primary and secondary outcomes.
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Assess and measure the natural history of facial skin changes in pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of compliance in each of the 4 assessment tools
Time Frame: 3 years
|
defined as the percentage of patients completing all the scheduled assessments under each assessment tool.
The percentage of compliance will be summarized and the associated 90% confidence interval reported.
If the percentage of compliance is 80% or higher under each assessment tool, the study will be considered feasible.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in skin health over the duration of the study (4 assessment points)
Time Frame: 3 years
|
Difference in skin health at each assessment from baseline will be calculated which will be divided by the standard deviation of the difference to obtain the effect size of the change at each assessment time post baseline
|
3 years
|
Changes in body image / skin QOL at end of treatment compared to baseline
Time Frame: 3 years
|
Skindex16 will be used to assess.
Skin traits will be rated from 0 (never bothered) to 6 (always bothered).
The max score being 96, the least being 0.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 24, 2020
Primary Completion (Actual)
February 13, 2023
Study Completion (Actual)
February 13, 2023
Study Registration Dates
First Submitted
July 10, 2019
First Submitted That Met QC Criteria
July 26, 2019
First Posted (Actual)
July 29, 2019
Study Record Updates
Last Update Posted (Actual)
September 5, 2023
Last Update Submitted That Met QC Criteria
August 31, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-2444.cc
- P30CA046934 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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